The Effectiveness of Auricular Acupuncture on Improving Secretion of Saliva Among Institutional Older Population

April 25, 2022 updated by: Huang, Hui-Chuan, Taipei Medical University
The study aims to examine the effect of auricular acupuncture on improving oral health in older population. The hypothesis of this study is that older people receiving auricular acupuncture can increase salivary secretion. By identifying the effectiveness of auricular acupuncture can increase salivary secretion; suitable care can be suggested to improve oral health in older population living in long-term institutions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The elderly living in long-term institutions are mostly limited to physical dysfunction and highly dependence. In addition, the chronic diseases are affected by taking a variety of drugs, which may easily lead to dry mouth. Thus, providing oral health to increase secretion of saliva is high recommended to those older population. The study is used to examine the effect of auricular acupuncture on improving oral health in older population. The eligible participants are random assign to experimental group receiving auricular acupuncture and control group having ineffective auricular acupuncture. Outcome measures include demographic variables, general health status and secretion of saliva, such as: Subjective dry mouth condition and objective mouth condition. Generalized linear model will be used to examine the effect of auricular acupuncture on improving oral health. By identifying the effectiveness of auricular acupuncture can increase salivary secretion; suitable care can be suggested to improve oral health in older population living in long-term institutions.

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Yilan City, Taiwan, 26443
        • Yilan Yuanshan Hopsital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Residents in long-term institutions aged over 65 years old
  2. Living in long-term institutions at least six months and above
  3. Having normal cognitive functions with Mini-Mental State Examination scores more than 25 scores.

Exclusion Criteria:

  1. The resident whose acupuncture point has Trauma, eczema or ulcer.
  2. Incapable of salivary secretion caused by disease,sush as radiation-induced xerostomia among patients with nasopharyngeal carcinoma, Sjogren's Syndrome,acute sialadenitis,chronic recurrent sialadenitis,viral salivary gland infection,salivary gland stones.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: True auricular acupuncture
Effective auricular acupuncture
Other: True auricular acupuncture
The participant in experimental group will receive acupuncture on ear Shenmen point, ear zero point, and Salivary glands.
Sham Comparator: Sham auricular acupuncture
Ineffective auricular acupuncture
Other: sham auricular acupuncture
The participant in control group will receive acupuncture on ineffective point at ear.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective dry mouth health
Time Frame: pre-test and post-test
self-rated salivation
pre-test and post-test
Objective dry mouth health
Time Frame: pre-test and post-test
Salivation measured by Oral moisture meter
pre-test and post-test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2020

Primary Completion (Actual)

September 2, 2020

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

July 26, 2020

First Submitted That Met QC Criteria

August 9, 2020

First Posted (Actual)

August 11, 2020

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N202001048

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Salivary Gland Diseases

Clinical Trials on True auricular acupuncture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe